Atlas FDA

INFUSION PUMP & IV SETS #4000

FDA 510(k) clearance K832755 · decided 1983-11-03

Clearance details

K-number
K832755
Device name
INFUSION PUMP & IV SETS #4000
Applicant
Omni-Glow, Inc.
Decision
Substantially Equivalent
Date received
1983-08-16
Decision date
1983-11-03
Days to decision
79 days
Clearance type
Traditional
Product code
FRN
Device class
2
Regulation number
880.5725
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
RemunityPRO+ Pump for Remodulin® (treprostinil) Injection (K253703)Deka R&D Corp2026-07-24
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MRidium 3870 MRI Infusion Pump System (3870) (K242752)Iradimed Corporation2025-05-28
BD Alaris Infusion System with Guardrails Suite MX (K243855)Carefusion 303, Inc.2025-04-25
Plum Solo™ Precision IV Pump (K242114)Icu Medical, Inc.2025-04-02
Plum Duo™ Precision IV Pump (K242115)Icu Medical, Inc.2025-04-02
RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (K250357)Deka Research & Development Corp.2025-03-11
Remunity 2.0 Pump for Remodulin (treprostinil) Injection (K241736)Deka Research and Development Corp.2025-01-16
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min) (K242735)Belmont Medical Technologies2024-12-23
Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets (K242660)Zevex, Inc.2024-10-03

Recalls involving this device

RecordFirmDate
Latex-free. Midlength Secondary I.V. Set, convertible pin, 40 inch with extension hook for recall (Z-1341-2010)Hospira Inc.2010-04-15
Latex-free, Primary I.V. Pump Set with distal microbore patient line and gravity flow prev recall (Z-1351-2010)Hospira Inc.2010-04-15
Lifeshield, latex-free, Primary I.V. Pump Set with distal microbore patient line and gravi recall (Z-1352-2010)Hospira Inc.2010-04-15
Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line, converti recall (Z-1353-2010)Hospira Inc.2010-04-15
Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line and Gravi recall (Z-1354-2010)Hospira Inc.2010-04-15
Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line and Gravi recall (Z-1355-2010)Hospira Inc.2010-04-15
Lifeshield, latex-free Primary I.V. Pump set with Distal Microbore Patient Line and Pressu recall (Z-1356-2010)Hospira Inc.2010-04-15
Lifeshield, latex-free, Primary I.V. Pump Set with Distal Microbore Patient Line, converti recall (Z-1357-2010)Hospira Inc.2010-04-15
Lifeshield, latex-free Primary I.V. Pump Set with Distal Microbore Patient Line, Convertib recall (Z-1358-2010)Hospira Inc.2010-04-15
LifeShield Latex-Free Primary I.V. Set, Convertible Pin, 83 inch, with Backcheck Valve and recall (Z-0505-06)Hospira Inc.2006-02-08
Vented and Non-Vented Burette I.V. Gravity Feed Administration Sets; sterile, Rx, single u recall (Z-0955-03)Abbott Laboratories HPD/ADD2003-06-27
Primary I.V. Gravity Administration Sets; sterile, Rx, single use devices; Abbott Laborato recall (Z-0957-03)Abbott Laboratories HPD/ADD2003-06-27
I.V. Pump Sets with Cassettes for use with Abbott Plum Series and Lifecare Infusion Pumps; recall (Z-0958-03)Abbott Laboratories HPD/ADD2003-06-27
Secondary I.V. Gravity Feed Sets; sterile, Rx, single use devices; Abbott Laboratories, No recall (Z-0959-03)Abbott Laboratories HPD/ADD2003-06-27
Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Se recall (Z-0936-03)Abbott Laboratories HPD/ADD2003-06-17
LifeShield Latex-Free Microdrip Soluset 100 mL Burette Plumset Convertible Pin, 121-1/2 In recall (Z-0915-03)Abbott Laboratories HPD/ADD2003-06-05